What the label lists and what reports show
Pirfenidone side effects
Pirfenidone's FDA label: “The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight …” FAERS holds 40,482 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (5,174 reports).
- Generic listed
Check it at the source: the pirfenidone FDA label on DailyMed (effective July 22, 2025, Laurus Labs Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of pirfenidone?Pirfenidone may cause serious side effects, including: • liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with pirfenidone. • sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking pirfenidone?” • severe skin reactions. Call your doctor right away if you have a severe skin reaction such as skin blisters, rash, sores in the mouth, hives or any other severe skin symptoms. Your doctor may stop your treatment with pirfenidone. • stomach problems. […]
Source: FDA drug label, Laurus Labs Limited, effective July 22, 2025 (SPL set 29b0fd0e-5a2b-4da7-8524-177dc28bf55e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
Table 2. Adverse Reactions Occurring in ≥10% of Pirfenidone-Treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3
| Reaction | Adverse Reaction Pirfenidone 2,403 mg/day (N = 623) | % of Patients (0 to 118 Weeks) Placebo (N = 624) |
|---|---|---|
| Nausea | 36% | 16% |
| Rash | 30% | 10% |
| Abdominal Pain 1 | 24% | 15% |
| Upper Respiratory Tract Infection | 27% | 25% |
| Diarrhea | 26% | 20% |
| Fatigue | 26% | 19% |
| Headache | 22% | 19% |
| Decreased Appetite | 21% | 8% |
| Dyspepsia | 19% | 7% |
| Dizziness | 18% | 11% |
| Vomiting | 13% | 6% |
| Gastro-esophageal Reflux Disease | 11% | 7% |
| Sinusitis | 11% | 10% |
| Insomnia | 10% | 7% |
| Weight Decreased | 10% | 5% |
| Arthralgia | 10% | 7% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1) ] Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Gastrointestinal Disorders [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of pirfenidone has been evaluated in more than 1,400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials. …
Source: FDA drug label, Laurus Labs Limited, effective July 22, 2025 (SPL set 29b0fd0e-5a2b-4da7-8524-177dc28bf55e), via openFDA; the full label on DailyMed
What do FAERS reports show?
40,482 reports list pirfenidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,421 are coded as a death and 7,848 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pirfenidone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions